5 results
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52ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Soundable Health Korea, Inc. (Subsidiary of Soundable Health, Inc.)
FDA registration
Soundable Health Korea, Inc. (Subsidiary of Soundable Health, Inc.)·1 product·🇰🇷 South Korea
proudP
FDA UDI
Soundable Health, Inc.·00860006184926·proudP is a mobile application intended for mea...
proudP
FDA UDI
Soundable Health, Inc.·00860006184902·proudP is a mobile application intended for mea...
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
FDA Recall
Terminated
·Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) Seocho-Daero, Seocho # 413 398 Platinum Tower Seoul Korea (the Republic of)·Product code EXY·April 21, 2022
ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier
FDA Enforcement
Class II
·Terminated·Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)·July 6, 2022